Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block

This study has been completed.
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00988234
First received: October 1, 2009
Last updated: February 16, 2011
Last verified: February 2011

October 1, 2009
February 16, 2011
April 2009
December 2010   (final data collection date for primary outcome measure)
  • Block success defined as loss of sensation to pinprick in each of the lumbar plexus and sciatic nerve distributions when measured 30 min after block performance. [ Time Frame: 30min ] [ Designated as safety issue: No ]
  • Motor blockade was evaluated by assessing the strength of knee extension (femoral nerve), thigh adduction (obturator nerve), and plantar flexion and dorsiflexion of the ankle (sciatic nerve) 30 min after block performance. [ Time Frame: 30min ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00988234 on ClinicalTrials.gov Archive Site
block execution time, depth of the nerve, needle depth, duration of the sensory and motor blockade, complications such as inadvertent needle puncture of epidural space, dural puncture, peritoneal puncture, and kidney or ureter puncture and nerve injury. [ Time Frame: within 48h ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block
Comparison of Lateral Decubitus Position Versus Prone Position for Ultrasound Guided Posterior Lumbar Plexus Block and Sciatic Nerve Block

In the present study, the investigators will test the effect of two position on posterior lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.

The posterior lumbar plexus block approach was described approximately 30 years ago, using surface anatomical landmarks and a loss-of-resistance technique, but over the years it was almost abandoned for its low successful rate, the huge numbers of adverse effects and its difficulties to be performed. The introduction of the nerve stimulator and ultrasound guided technique in recent years increased the success rate in various peripheral nerve blocks and decreased adverse effects. Ultrasound guided LPB as well as sciatic nerve block technique in a small patient population resulting in a encouraging result, but published clinical data on optimal patient position for ultrasound-guided LPB are limited. We designed this prospective randomized study to compare the success rate, time of performance and complications of ultrasound guided posterior lumbar plexus block as well as subgluteal or sub-greater trochanter sciatic nerve block under lateral decubitus position v.s. prone position.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lower Limb Surgery
  • Procedure: SGPP
    ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position
  • Procedure: SGTPP
    ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position
  • Procedure: SGLP
    ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position
  • Procedure: SGTLP
    ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position
  • Experimental: SGPP
    ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position
    Intervention: Procedure: SGPP
  • Experimental: SGTPP
    ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position
    Intervention: Procedure: SGTPP
  • Experimental: SGLP
    ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position
    Intervention: Procedure: SGLP
  • Experimental: SGTLP
    ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position
    Intervention: Procedure: SGTLP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 to 75 years old
  • elective unilateral lower limb surgery
  • ASA Physical Status ASA I-III

Exclusion Criteria:

  • age <18 or >75 year old
  • ASA Physical Status >ASA III
  • abnormal blood coagulation
  • infection near puncture place
  • nerve injury
  • bilateral lower limb surgery
  • patients with lumbar vertebral trauma
  • inability to be properly positioned
  • chronic narcotic therapy or illicit drug use
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00988234
TJHMZK01001
Yes
Yuke Tian/ Professor, Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology
Huazhong University of Science and Technology
Not Provided
Study Chair: Yuke Tian, MD. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Huazhong University of Science and Technology
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP